Methods, systems and devices for treating glaucoma

Abstract

A system is provided including an elongate needle body and an aqueous humor drainage device. The drainage device includes an elongated flexible tube that is operatively coupled to a proximal end of the needle body. Methods for the implantation of the aqueous humor drainage device in the eye are provided. A system including an elongate needle body and drainage device is also provided for draining other body cavities.

What is claimed is: 
     
       1. A method for the treatment of ocular pressure comprising:
 providing a system including a needle device and an aqueous humor drainage device, wherein the needle device includes a needle body having a sharp distal end and a proximal end, and the aqueous humor drainage device includes an elongate flexible tube with opposed first and second ends, wherein the first end of the tube is attached to the proximal end of the needle body opposite the second end of the tube and the tube extends away from the proximal end of the needle body outside the needle body; 
 inserting the sharp distal end of the needle body through an entrance site in eye tissue to form tissue passageways leading to and from the anterior chamber of the eye, and maneuvering the needle body through eye tissue such that the sharp distal end of the needle exits from an exit site in eye tissue spaced from the entrance site and extends beyond such exit site; and 
 severing the tube from the proximal end of the needle body such that tube is not attached to the needle body. 
 
     
     
       2. A method according to  claim 1 , wherein:
 the maneuvering of the needle body involves pushing the needle body through eye tissue. 
 
     
     
       3. A method according to  claim 1 , wherein:
 the severing involves severing a part of the tube that extends beyond the exit site. 
 
     
     
       4. A method according to  claim 1 , further comprising:
 pulling a portion of the needle body that extends beyond the exit site such that the needle body and tube are pulled through the tissue passageways with at least the first end of the tube that is coupled to the proximal end of the needle extending beyond the exit site. 
 
     
     
       5. A method according to  claim 1 , further comprising:
 defining a drainage bleb over a localized portion of the eye tissue; and 
 positioning the tube such that it provides fluid communication between the anterior chamber of the eye and the drainage bleb to allow for aqueous humor to drain from the anterior chamber of the eye through the tube into the drainage bleb. 
 
     
     
       6. A method according to  claim 5 , wherein:
 the drainage bleb is formed between Tenon's membrane and/or the conjunctiva and the sclera. 
 
     
     
       7. A method according to  claim 5 , wherein:
 the drainage bleb is defined over a localized portion of the eye tissue adjacent a portion of the tube that extends beyond the exit site; and 
 the positioning of the tube includes positioning the portion of the tube that extends beyond the exit site into the drainage bleb and positioning the second end of the tube in the anterior chamber of the eye. 
 
     
     
       8. A method according to  claim 7 , wherein:
 the entrance site is in the cornea of the eye, and the exit site is in the sclera or conjunctiva of the eye. 
 
     
     
       9. A method according to  claim 8 , wherein:
 the tissue passageways formed by the needle body include a first section that extends through the cornea and into the anterior chamber of the eye and a second section that extends from anterior chamber of the eye through the sclera under the limbus of the eye. 
 
     
     
       10. A method according to  claim 5 , wherein:
 the drainage bleb is defined over a localized portion of the eye tissue adjacent a portion of the tube that extends beyond the entrance site; and 
 the positioning of the tube includes pulling on the portion of tube that extends beyond the entrance site in order to position the first end portion of the tube in the anterior chamber of the eye and positioning the portion of the tube that extends beyond the entrance site into the drainage bleb. 
 
     
     
       11. A method according to  claim 10 , wherein:
 the entrance site is in the sclera or conjunctiva of the eye, and the exit site is in the cornea of the eye. 
 
     
     
       12. A method according to  claim 10 , wherein:
 the tissue passageways formed by the needle body include a first section that extends through the sclera under the limbus and into the anterior chamber of the eye and a second section that extends from the anterior camber of the eye and though the cornea of the eye. 
 
     
     
       13. A method according to  claim 1 , wherein:
 the entrance site and exit site are in eye tissue on opposite sides of the limbus of the eye. 
 
     
     
       14. A method according to  claim 13 , wherein:
 one of the entrance site and exit site is in the cornea of the eye, and the other of the entrance site and exit site is in the sclera or conjunctiva of the eye. 
 
     
     
       15. A method according to  claim 1 , wherein:
 the needle body has at least one of the following characteristics: 
 a straight configuration or curved configuration, and
 a gauge that is between 30 G and 22 G. 
 
 
     
     
       16. A method according to  claim 1 , wherein:
 the tube has at least one of the following characteristics: 
 at least one section of the tube has an outer diameter that is at least as large as (or greater than) the maximum diameter of the needle body, 
 the ratio of the outer diameter of the tube to the outer diameter of the needle body is in the range of 1 to 3, and more preferably in the range of 1.1 to 1.8, and 
 an outer diameter that is between 100 μm and 700 μm. 
 
     
     
       17. A method according to  claim 1 , wherein:
 the aqueous humor drainage device includes at least one element that extends radially outward from the exterior surface of an intermediate portion of the tube. 
 
     
     
       18. A method according to  claim 17 , wherein:
 the at least one element is bulbous in shape. 
 
     
     
       19. A method according to  claim 17 , wherein:
 the at least one element aids in locating and/or fixing the position of the aqueous humor drainage device in the preferred location in the eye. 
 
     
     
       20. A method according to  claim 17 , wherein:
 the at least one element includes an element that remains in the anterior chamber of the eye after implantation of the aqueous humor drainage device into the eye. 
 
     
     
       21. A method according to  claim 1 , wherein:
 the aqueous humor drainage device further includes a visual indicator that indicates a proper place where the tube should be cut or otherwise trimmed. 
 
     
     
       22. A method according to  claim 1 , wherein:
 the aqueous humor drainage device is be formed from a synthetic polymer. 
 
     
     
       23. A method according to  claim 1 , wherein:
 the entrance site is formed by the needle body or is an incision. 
 
     
     
       24. A method according to  claim 1 , wherein:
 the tube is attached to the proximal end of the needle body by at least one of an adhesive, a swagged fitting, a crimping, a whipping, a suture or combinations thereof. 
 
     
     
       25. A method according to  claim 1 , wherein:
 the tube is attached to the proximal end of the needle body by an abrupt transition or tapered transition. 
 
     
     
       26. A method for the treatment of ocular pressure comprising:
 providing a system including a needle device and an aqueous humor drainage device, wherein the needle device includes a needle body having a sharp distal end and a proximal end, and the aqueous humor drainage device includes an elongate flexible tube with opposed first and second ends, wherein the first end of the tube is attached to the proximal end of the needle body and the tube extends away from the proximal end of the needle body outside the needle body; 
 inserting the sharp distal end of the needle body through an entrance site in eye tissue to form tissue passageways leading to and from the anterior chamber of the eye, and maneuvering the needle body through eye tissue such that the sharp distal end of the needle exits from an exit site in eye tissue spaced from the entrance site and extends beyond such exit site; 
 pulling a portion of the needle body that extends beyond the exit site such that the needle body and tube are pulled through the tissue passageways with at least the first end of the tube that is coupled to the proximal end of the needle extending beyond the exit site; 
 defining a drainage bleb over a localized portion of the eye tissue adjacent a portion of the tube that extends beyond the exit site; and 
 severing the tube from the proximal end of the needle body such that the tube is not attached to the needle body and positioning the tube such that it provides fluid communication between the anterior chamber of the eye and the drainage bleb to allow for aqueous humor to drain from the anterior chamber of the eye through the tube into the drainage bleb. 
 
     
     
       27. A method according to  claim 26 , wherein:
 the drainage bleb is formed between Tenon's membrane and/or conjunctiva and the sclera. 
 
     
     
       28. A method according to  claim 26 , wherein:
 the positioning of the tube includes positioning the portion of the tube that extends beyond the exit site into the drainage bleb and positioning the second end of the tube in the anterior chamber of the eye.